Baxter International Inc. (BAX) and Halozyme Therapeutics Inc.
(HALO) received a Food and Drug Administration request for
additional information related to the long-term use of their
investigational product called HyQ.
The FDA's request delays any potential approval of HyQ, a
treatment that aims to allow physicians to tailor antibody drug
therapy to lifestyle and medical needs of patients with
immune-system disorders.
Baxter and Halozyme said in a statement that they will work
closely together to develop studies to provide additional data to
address concerns.
HyQ, which is based on a Baxter IV drug, targets a condition
called primary immunodeficiency, which can involve any of more than
150 diseases that cause the immune system to function poorly or not
at all. At least 250,000 Americans have the condition, many of them
children.
Shares of Baxter closed Friday at $58.03 and were inactive
premarket. Halozyme shares closed Friday at $11.27 and were halted
in recent premarket trading.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;
Tess.Stynes@dowjones.com